Global Regulatory Labeling Lead

Socket.dev; Foster City (CA); Hybrid; USD 175,000 - 195,000; Full time

Job summary

Mirum Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs Labeling to lead global labeling strategy and documentation for marketed and development products. You will partner with Regulatory Affairs, Medical, Legal, Clinical Development, Commercial and International distributors, and lead the Label Working Group.

The role requires strong knowledge of FDA, EU and international labeling regulations, experience with US/EU labeling, and the ability to manage multiple projects across

Qualifications

• Minimum 3–6 years of regulatory labeling experience in biopharma.
• Experience with US/EU labeling and cross-border submissions.
• Experience leading cross-functional teams on labeling projects.

Responsibilities

• Create and update labeling content for US and international regions.
• Lead Label Working Group and provide strategic regulatory guidance.
• Coordinate labeling submissions and translations with internal and external partners.
• Ensure compliance with FDA, EU, and international labeling regulations.

Skills

Regulatory labeling expertise

FDA/International health authority

Labeling leadership

Cross-functional collaboration

Project management

Veeva Vault RIM

Education

Bachelor's degree in sciences

Tools

Veeva Vault RIM

QualityDocs

Job description

Mirum Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs Labeling to lead global labeling strategy and documentation for marketed and development products. You will partner with Regulatory Affairs, Medical, Legal, Clinical Development, Commercial and International distributors, and lead the Label Working Group.

The role requires strong knowledge of FDA, EU and international labeling regulations, experience with US/EU labeling, and the ability to manage multiple projects across